Healing Gardens: Leveraging Serious Games to Deliver Accessible Pain-CBT and Pharmacologic Support for Patients With Advanced Cancer Managing Pain
Visão geral do estudo
Status
Condições
Descrição detalhada
This is a single-site, interventional feasibility/pilot study evaluating Healing Gardens, a technology-based serious game intervention designed to deliver pain-CBT and cancer pain education for patients with advanced cancer and chronic pain. The study is intended to refine the intervention and establish its initial feasibility, acceptability, and usability through Cohort A content refinement/user acceptability testing and Cohort B pre-pilot testing.
Study procedures include screening and recruitment from DFCI outpatient oncology and palliative care clinics and DFCI satellite clinics at South Shore Health; baseline assessments; medical record abstraction; qualitative interviews and optional focus group/community advisory board activities for Cohort A; usability and acceptability surveys for both cohorts; and, for Cohort B, at-home use of the Healing Gardens game for up to 12 weeks with study contacts to address technical issues and complete end-of-study assessments. Study procedures may be conducted in person, by phone, or through secure HIPAA-compliant video platforms.
It is expected that up to 46 participants will take part in this study, including up to 25 participants in Cohort A and up to 21 participants in Cohort B.
Participation length varies by cohort. Cohort A participants will complete a 30-60 minute interview/user acceptability testing session and may optionally participate in community advisory board meetings up to twice monthly during Year 1. Cohort B participants will test the game at home for up to 12 weeks and complete baseline and end-of-study assessments and a 30-60 minute semi-structured interview. Overall subject accrual and participation are expected to occur over approximately 29 months. There is no long-term follow-up for this study.
This is a DF/HCC PI-sponsored study with funding/support listed from Dana-Farber/Harvard Cancer Center and the National Cancer Institute/NIH/DHHS (R34CA308746, pending).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Desiree Azizoddin, PsyD
- Número de telefone: 626-826-7984
- E-mail: Desiree_azizoddin@DFCI.Harvard.edu
Estude backup de contato
- Nome: Desiree R Azizoddin, PsyD
- Número de telefone: 626-826-7984
- E-mail: Desiree_azizoddin@DFCI.Harvard.edu
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Dana-Farber Cancer Institute
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Contato:
- Desiree R Azizoddin, PsyD
- Número de telefone: 626-826-7984
- E-mail: Desiree_azizoddin@DFCI.Harvard.edu
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Weymouth, Massachusetts, Estados Unidos, 02190
- Dana-Farber Cancer Institute at South Shore
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Contato:
- Meredith Faggen, MD
- Número de telefone: 781-624-4800
- E-mail: Meredith_Faggen@dfci.harvard.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age ≥ 18 years
- Patient is diagnosed with a locally advanced or metastatic solid tumor malignancy, either undergoing active treatment or receiving treatment for an advanced cancer or are receiving supportive/palliative care at DFCI
- Chronic pain related to cancer or treatment (> pain score of 4 on a 0-10 scale on average over the past two weeks, Numeric Rating Scale)
- Own/use a compatible device (e.g., smartphone, laptop)
Exclusion Criteria:
- Patients in survivorship: patients who have completed their treatment regimens, are not actively receiving curative or palliative treatment for an advanced cancer, or have a cancer that is in remission
- Cognitive impairment that would interfere with study participation, as judged by the treating clinician (e.g. delirium, dementia)
- Inability to speak English (the intervention has not yet been translated to other languages)
- Enrolled in hospice
- Currently hospitalized
- Pain primarily related to a recent surgery (within the last 2 weeks)
- Conditions that hinder device use (e.g., vision impairment)
- We will exclude adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Content Development and Refinement
Participants complete a baseline assessment, a semi-structured interview for content development and refinement and/or optional focus groups, and usability/acceptability surveys.
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Participant feedback activities used to optimize the Healing Gardens serious game and related patient-facing content.
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Experimental: Pre-pilot User Acceptability Testing
Participants complete a baseline assessment, at-home testing of the Healing Gardens game for up to 12 weeks, a semi-structured debriefing interview, and end-of-intervention surveys.
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A story-led mHealth serious game delivering pain-CBT and cancer pain education, including pain psychoeducation, pain coping skills, cognitive restructuring, and safe/effective opioid use content.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Score of Acceptability E-Scale
Prazo: At completion of the participant's game testing period (up to 12 weeks)
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Acceptability E-scale is a 6-item self-reported measure of participant acceptability of the intervention.
Each item is rated on a 5-point Likert scale, yielding a total score ranging from 6 to 30, with higher scores indicating greater acceptability of the intervention.
The intervention will be considered acceptable if the mean score exceeds 24 out of 30.
(Tariman et al., Appl Nurs Res 2011)
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At completion of the participant's game testing period (up to 12 weeks)
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Mean Score of System Usability Survey (SUS)
Prazo: At completion of the participant's game testing period (up to 12 weeks)
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SUS is a 10-item questionnaire used to assess the usability of the intervention.
SUS is scored on a scale 0-100 with higher scores representing better acceptability.
A score of 75 or higher is deemed acceptable.
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At completion of the participant's game testing period (up to 12 weeks)
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Module Completion Rate
Prazo: At completion of the participant's game testing period (up to 12 weeks)
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Module completion rate is defined as the proportion of participants who complete at least 75% of intervention modules (4 of 5 modules).
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At completion of the participant's game testing period (up to 12 weeks)
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Recruitment Success Rate
Prazo: During the 12-month enrollment period beginning in Year 2 of the study.
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Recruitment success rate is defined as the proportion of months during the enrollment period in which at least 8 participants provided informed consent.
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During the 12-month enrollment period beginning in Year 2 of the study.
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Retention Rate
Prazo: At completion of the participant's game testing period (up to 12 weeks after enrollment, with enrollment beginning in Year 2).
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Retention rate is defined as the proportion of participants who complete the follow-up assessments and provide study data.
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At completion of the participant's game testing period (up to 12 weeks after enrollment, with enrollment beginning in Year 2).
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Desiree Azizoddin, PsyD, Dana-Farber Cancer Institute
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26-075
- R34CA308746 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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